VarmX Secures $117M Upfront in Strategic Deal with CSL for Phase III Asset VMX-C001

On September 16, Dutch biotechnology company VarmX announced a strategic partnership with CSL, the global leader in plasma-derived therapies, to support the development of its lead asset, VMX-C001. VMX-C001 is a novel therapeutic agent designed to restore hemostasis in patients requiring emergency surgery or experiencing severe bleeding while on factor Xa-inhibiting direct oral anticoagulants (FXa DOACs). CSL has also entered into an exclusive option agreement with VarmX’s shareholders to acquire all issued and outstanding shares of the company.

Under the terms of the agreement, CSL will fully fund VarmX’s global Phase III EquilibriX-S trial. CSL will also fully fund and support VarmX in late-stage product development, manufacturing, and pre-launch commercial and medical affairs activities. Upon closing of the transaction, CSL will pay VarmX shareholders an upfront payment of $117 million (approximately RMB 830 million) to secure an exclusive option to acquire the company. CSL will have the right to exercise this option following the availability of Phase III clinical data. Subject to the achievement of milestones, the exercise of the option, and customary regulatory approvals, VarmX shareholders will receive an additional $388 million in acquisition and other payments through the formal commercialization of VMX-C001, as well as up to $1.7 billion in sales milestone payments thereafter. The total value of this collaboration amounts to $2.205 billion, approximately RMB 15.6 billion.

Compared with other high-profile giants that frequently engage in aggressive global acquisitions, CSL may not enjoy the same level of name recognition. However, in the field of blood products, the company boasts a prestigious reputation. With a history spanning over a century, CSL traces its origins to the Commonwealth Serum Laboratories, established in 1916. In 1994, the company was privatized, renamed CSL Limited, and listed on the Australian Securities Exchange.After acquiring Aventis Behring in 2004 and merging with ZLB Bioplasma, CSL established CSL Behring, thereby becoming the world’s largest plasma-derived therapies manufacturer.

In 2024, CSL ranked 18th globally in prescription drug sales among multinational pharmaceutical companies, was the fourth-largest company by market capitalization on the Australian Securities Exchange (ASX), and owns CSL Plasma, one of the world’s largest plasma collection networks.In China, CSL has been providing human serum albumin to domestic patients since 1986 and is one of the major suppliers of this product in the Chinese market. Currently, the company primarily offers three imported human serum albumin products to Chinese patients: Alburex, Beriplex, and Behring.

Building on its foundation in plasma-derived therapies, CSL has established three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. The company focuses on the development and production of innovative medicines for the treatment of immune deficiencies, coagulation disorders, cardiovascular and metabolic diseases, respiratory conditions, and transplant rejection.

In the first half of this year, CSL still had four core business segments:① CSL Behring: Provides plasma-derived therapies and immunotherapies for rare diseases, hematological conditions, and immune-related disorders, and is one of the major suppliers of human serum albumin in the Chinese market. ② CSL Vifor: Joined the CSL Group in 2021 through the acquisition of Switzerland’s Vifor Pharma, focusing primarily on innovative medicines for iron deficiency anemia and kidney diseases. ③ CSL Plasma: The world’s largest plasma collection company. ④ CSL Seqirus: The world’s second-largest supplier of influenza vaccines.

However, in August, alongside the release of its financial report disclosing revenue, CSL announced a major development: it would spin off its vaccine business, CSL Seqirus, and eliminate 15% (approximately 3,000) of its global workforce.On the day the news was announced, both the Australian Securities Exchange (ASX) and Australia’s biopharmaceutical sector experienced significant turbulence. CSL’s share price plummeted by nearly 17%, wiping out approximately AUD 20 billion in market capitalization. CSL Seqirus, once regarded as CSL’s “second growth curve” beyond its plasma-derived therapies business, was established through a merger in 2015. Within just a few years after the merger, it grew into the world’s second-largest influenza vaccine company, trailing only Sanofi Pasteur, with a global market share approaching 25%. However, according to financial results for the period ending June 30, the division generated only USD 2.2 billion in revenue, accounting for 14% of CSL’s total revenue and achieving a marginal growth rate of just 2%.

CSL CEO Paul McKenzie described the weak vaccine market as “disappointing” during the earnings conference call, noting that Seqirus’s two core products were significantly impacted. Sales of Fluad declined by 14% to $901 million, while Flucelvax dropped by 12% to $474 million. In Mr. McKenzie’s view, “Given the risk-return profile of vaccines and the scale of disease burden, CSL considers the weakness in the U.S. seasonal category to be highly unreasonable, especially as this year’s disease burden has reached its highest level in 15 years.”

Amid various factors, CSL announced the spin-off of CSL Seqirus. At the same time, CSL also publicly stated that it was seeking opportunities to strengthen its clinical and commercial product portfolio. This strategic collaboration with VarmX is clearly a significant step in CSL’s active pursuit of new growth drivers.

VarmX Announcement: By 2030, an estimated 30 million patients in the United States, Europe, and Japan will be using direct oral anticoagulants (DOACs) targeting factor Xa (FXa) for chronic indications, including stroke prevention in atrial fibrillation and treatment of deep vein thrombosis. Although these therapies are effective, 2%–4% of patients annually experience severe, life-threatening bleeding events, sometimes requiring emergency surgery, affecting more than 30,000 patients each week.

VMX-C001 is an investigational, recombinant modified coagulation factor X protein that, via rapid single-dose administration, effectively bypasses the anticoagulant activity of factor Xa (FXa), enabling users of FXa-targeting direct oral anticoagulants (DOACs) who require emergency surgery or experience severe bleeding to rapidly restore hemostatic function.

In a previous study conducted at the Maastricht Coagulation Analysis Center in the Netherlands, researchers added VMX-C001, FXa-DOACs, andexanet alfa, or 4-factor PCC to platelet-poor plasma from healthy donors, using the endogenous thrombin potential (ETP) parameter from the thrombin generation (TG) curve as the experimental endpoint. The results showed that VMX-C001 restored thrombin generation in the presence of FXa-DOACs without inducing ETP overshoot; PCC failed to restore thrombin generation and caused ETP overshoot even in the absence of FXa-DOACs; andexanet alfa restored thrombin generation but also led to ETP overshoot due to neutralization of tissue factor pathway inhibitor (TFPI), an anticoagulant factor.

Furthermore, VMX-C001 may be used in combination with all factor Xa direct oral anticoagulants (DOACs) and other common anticoagulants such as heparin, potentially without an increased risk of thrombosis.

Currently, there are no fully approved therapeutic agents in the European Union and the United States for acute major bleeding in patients taking Factor Xa inhibitors, a significant clinical unmet need. Targeting this market, VMX-C001 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) on September 3, 2025, highlighting its potential to address the critical unmet medical need for restoring hemostasis in patients on direct oral anticoagulants (DOACs) targeting Factor Xa who require emergency surgery. The latest updates indicate that VMX-C001 is expected to be commercially launched in 2029.

Reference: “$90 Billion Evaporated in a Day! Massive Layoffs of 3,000 Employees, Divestiture of the Second-Largest Business Unit: Is Australia’s Leading Pharmaceutical Company Facing a ‘Life-or-Death’ Moment?”